The present invention relates to catheters, and in particular, to a diagnostic catheter device with an elongated balloon element disposed adjacent to a distal end thereof, which expands to occlude opposing openings of the cervical canal.
Diagnostic procedures which require a non-surgical entry into the uterus are well known. One such procedure known as hysterosalpingography, is a radiographic method for imaging the anatomical structures of the uterus and fallopian tubes. Hysterosalpingography involves inserting a fine flexible catheter through the cervical canal and injecting a contrast medium, such as an iodinated fluid, into the uterus. Radiography is then carried out to provide imaging information pertaining to the subject uterus and fallopian tubes.
Another well known diagnostic procedure which entails the non-surgical entry into the uterus is called hysterosonography. This procedure also employs a fine flexible catheter that is inserted into the cervical canal of the uterus. The catheter in this procedure enables the physician or technician to inject a sterile saline or water solution into the uterus to expand it so that an ultrasound scanner can be used to sonographically observe the uterus.
The catheters typically used in both procedures have some type of means for sealing off the uterus after injection of the fluid to prevent back-flow into the vaginal canal. One commonly employed means is an inflatable intrauterine balloon made from an elastomeric material. The balloon is usually disposed adjacent the distal tip of the catheter. A first lumen provided in the catheter communicates with the interior of the balloon to enable inflation and deflation of the balloon with an inflation syringe. A second lumen provided in the catheter enables a desired diagnostic fluid to be injected into the uterus with an injection syringe.
Such catheters are operated by inserting the distal tip thereof through the cervical canal and into the uterus with the intrauterine balloon deflated. The insertion of the distal tip operates to position the deflated intrauterine balloon in the uterus or cervical canal. Once positioned, the inflation syringe is used to inflate the intrauterine balloon with air or a saline solution to seal and block the cervical canal. The injection syringe can then be used to inject the desired diagnostic fluid into the uterus.
One problem associated with these balloon catheter designs is that they are relatively expensive to manufacture. Therefore, a less expensive diagnostic balloon catheter device is needed.
A catheter device for non-surgical entry into a uterus, comprises a tubular body having a lumen extending from a first end thereof to a second end thereof, the lumen having an external opening for dispensing a diagnostic fluid into the uterus. An elongated balloon is disposed distally on the tubular body for insertion into the cervical canal of the uterus, the balloon having opposing portions which occlude opposite openings of the cervical canal.
Another aspect of the invention involves a method for non-surgically entering a uterus to dispense a diagnostic fluid therein, the method comprises providing a catheter device comprising a tubular body having a lumen extending from a first end thereof to a second end thereof, an elongated balloon disposed distally on the tubular body, and an inflation sleeve slidably disposed over the tubular body. The first end of the tubular body is inserted through the cervical canal of the uterus so that the elongated balloon is positioned within the canal with opposing portions of the balloon adjacent openings of the canal. The inflation sleeve is slid over a section of one of the opposing portions of the balloon thereby inflating the opposing portions of the balloon to occlude the openings of the canal. The diagnostic fluid is then dispensed through the lumen of the tubular body into the uterus.